"We have submitted medical device report (MDRs), to the FDA for numerous serious injuries relating to use of the ReWalk Personal system, and have initiated a voluntary correction related to certain use instructions in the device’s labeling, which the FDA classified as a Class II recall. If our product may have caused or contributed to a death or a serious injury, or if our product malfunctioned and the malfunction’s recurrence would be likely to cause or contribute to a death or serious injury, we must comply with the FDA’s MDR regulations, which could result in voluntary corrective actions or FDA enforcement actions, such as mandatory recalls."
The bolded part didn't exist in previous quarterly reports, even though I am pretty sure that the injuries due to Rewalk happened all along. I can't necessarily assess how serious these injuries are or whether they can be prevented but that's a significant worry if one's going for broad insurance coverage.
Recent RWLK News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/22/2024 08:16:29 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 04/22/2024 08:15:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/19/2024 12:46:30 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/04/2024 01:01:24 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/03/2024 11:34:09 AM
- VA STAND Act introduced in the United States Senate • GlobeNewswire Inc. • 03/22/2024 12:30:00 PM
- Lifeward Announces Reverse Share Split • GlobeNewswire Inc. • 03/13/2024 03:45:17 PM
- ReStore Exo-Suit Publications Demonstrate Improved Walking Outcomes Versus Conventional Stroke Therapy • GlobeNewswire Inc. • 03/08/2024 01:30:00 PM
- Lifeward announces the Centers for Medicare & Medicaid Services (“CMS”) is deferring its final decision on the payment rate for personal exoskeletons so that more recent claims information on the current, more advanced ReWalk Personal Exoskeleton may b • GlobeNewswire Inc. • 03/01/2024 01:45:11 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/27/2024 02:15:46 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/27/2024 01:15:25 PM
- Lifeward Reports Fourth Quarter and Full Year 2023 Financial Results • GlobeNewswire Inc. • 02/27/2024 01:00:07 PM
- Lifeward to Report Fourth Quarter and Fiscal Year-End 2023 Financial Results on February 27, 2024 • GlobeNewswire Inc. • 02/20/2024 01:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/30/2024 09:15:24 PM
- ReWalk Robotics Transforms Company Identity, Rebrands as Lifeward • GlobeNewswire Inc. • 01/29/2024 01:00:00 PM
- ReWalk Robotics Expands Direct Sales Coverage to Canada • GlobeNewswire Inc. • 01/12/2024 01:30:00 PM
- ReWalk Robotics Ltd. to Present at Sidoti Virtual Investor Conference on January 17 • GlobeNewswire Inc. • 01/11/2024 10:00:06 PM
- First ReWalk Personal Exoskeleton Claim Paid by Medicare • GlobeNewswire Inc. • 01/05/2024 01:00:00 PM
- ReWalk Robotics CEO Issues Year-End 2023 Open Letter to Shareholders and Provides 2024 Commercial and Operational Priorities • GlobeNewswire Inc. • 01/04/2024 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/19/2023 09:04:05 PM
- ReWalk Robotics Presents on Personal Exoskeleton Pricing at Medicare Public Meeting • GlobeNewswire Inc. • 11/30/2023 09:45:00 PM
- ReWalk Robotics Demonstrates AI Autonomous Decision Making in Next Generation Exoskeleton Prototype • GlobeNewswire Inc. • 11/28/2023 01:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/21/2023 09:37:18 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 11/20/2023 11:39:22 AM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 11/17/2023 11:22:31 AM
Bantec Reports an Over 50 Percent Increase in Sales and Profits in Q1 2024 from Q1 2023 • BANT • Apr 25, 2024 10:00 AM
Cannabix's Breath Logix Alcohol Device Delivers Positive Impact to Private Monitoring Agency in Montana, USA • BLO • Apr 25, 2024 8:52 AM
Kona Gold Beverages, Inc. Announces Name Change to NuVibe, Inc. and Initiation of Ticker Symbol Application Process • KGKG • Apr 25, 2024 8:30 AM
Axis Technologies Group and Carbonis Forge Ahead with New Digital Carbon Credit Technology • AXTG • Apr 24, 2024 3:00 AM
North Bay Resources Announces Successful Equipment Test at Bishop Gold Mill, Inyo County, California • NBRI • Apr 23, 2024 9:41 AM
Epazz, Inc.: CryObo, Inc. solar Bitcoin operations will issue tokens • EPAZ • Apr 23, 2024 9:20 AM